Regulatory Affairs Director for Rare Disease Therapies

14 hours ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time

Company Overview:

CT19 is a European biotech organisation dedicated to developing novel therapeutics for rare diseases. With a strong portfolio ranging from preclinical to approved products, the company is expanding its pipeline with multiple new indications.

About the Role:

This exciting opportunity is for a Senior Director to lead Regulatory Affairs as Therapeutic Area Head. Reporting directly to the Global Head of Regulatory, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets. Your strategic decisions will drive the direction of the portfolio, making this role highly visible within the organisation.

Responsibilities:

  • Lead a small team of Regulatory professionals, providing direction and motivation while giving them a voice at the table.
  • Ensure regulatory approval for a diverse pipeline of assets through strategic decision-making.
  • Collaborate closely with senior stakeholders, including Commercial & General Managers, to drive commercial strategy.
  • Oversight of multiple products at different stages of their development lifecycle.

Requirements:

  • Experience in marketing applications to FDA and EMA required.
  • Rare disease and orphan drug experience essential.
  • Haematology, rheumatology, or dermatology experience beneficial.
  • People management experience with direct report oversight required.
  • Commercial strategy experience and product portfolio oversight ideal.

Estimated Salary: £120,000 - £150,000 per annum, depending on experience. This salary reflects the role's responsibilities, location, and industry standards.



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